Surgical staple implant system

Abstract

A sterile staple implant system is provided for use during a surgery. The staple implant system comprises a group of complementary surgery-specific instruments that are packaged in a sterile state. An instrument tray is configured to preserve the instruments in the sterile state until the staple implant system is opened during the surgery. The instrument tray is configured to provide the surgeon with easy access to the instruments during the surgery. The staple implant system comprises at least a staple inserter and a surgical staple suitable for being implanted in parallel holes drilled across a bone fusion or fixation site of a patient. The surgical staple preferably is loaded in a relaxed configuration into the staple inserter. A staple retention clip retains the surgical staple in the staple inserter until the staple is distracted during the surgery.

What is claimed is: 
     
         1 . A sterile staple implant system for use during a surgery, comprising:
 a staple inserter; comprising a distal force applicator, and a first grip and a second grip;   wherein the staple inserter is stored with a surgical staple in a relaxed configuration, and engaged with the first and second grip using a staple retention clip;   wherein the surgical staple comprises a crown coupled with a first leg at a first end and coupled with a second leg at a second end;   the first leg and second leg comprising a multiplicity of teeth disposed along an inner side of each of the legs and biased toward the crown that facilitate inserting the staple into bone and discourage the staple from backing out of the bone after implantation; and wherein   the staple inserter comprises:   a proximal handle comprising a directional indicator and mechanically coupled to a driver, wherein the proximal handle is configured to:   advance a shaft and move the driver distally towards the crown in response to rotating the proximal handle in a first direction, thereby distracting the surgical staple; and   relax the surgical staple in response to rotating the proximal handle in a second direction;   the staple retention clip configured to keep the crown fixedly engaged with the first and second grip of the staple inserter;   wherein the staple retention clip retains the surgical staple in a relaxed state during sterilization, packaging, and shipping, and prevents the crown from becoming dislodged from the distal force applicator;   wherein the first grip of the staple inserter is positioned with respect to the first leg of the surgical staple, and wherein a second grip of the staple inserter is positioned with respect to the second leg of the surgical staple;   wherein the first and second grips contact opposite ends of an underside of the crown;   a group of complementary surgery-specific instruments that are packaged in a sterile state comprising a tamp configured to push the first leg and second leg into a plurality of osteotomy holes, the staple inserter, the surgical staple, a bone drill, a drill guide, and a locator pin; and   an instrument tray configured to preserve the instruments in the sterile state and provide easy access to the instruments during the surgery,   
       wherein once the surgical staple is in the distracted configuration, the first and second legs of the surgical staple are configured to be slid into parallel holes across a fixation site of a patient. 
     
     
         2 . The system of  claim 1 , wherein the staple retention clip is configured to be removed from the staple inserter during or after distracting the surgical staple prior to being implanted into a bone of a patient. 
     
     
         3 . The system of  claim 1 , wherein the group of instruments further comprises any of various surgical tools, such as drill sizers, forceps, staple removal tools, temporary pins, drill depth stops, fusion bone plates, bone plate fasteners, compression screws, and the like. 
     
     
         4 . The system of  claim 1 , wherein the plurality of teeth are configured to engage with a bone. 
     
     
         5 . The system of  claim 4 , wherein the surgical staple includes wing portions disposed at opposite ends of the crown and extending beyond the first leg and the second leg, the wing portions being configured to cooperate with at least the plurality of teeth to fixate the surgical staple once implanted in the bone. 
     
     
         6 . The system of  claim 5 , wherein the wing portions are configured to receive a first grip and a second grip comprising the staple inserter for placing the surgical staple into a distracted configuration suitable for implantation into a bone. 
     
     
         7 . The system of  claim 1 , wherein the crown includes an upper reinforced portion and a valley disposed underneath the reinforced portion and bordered by edges, the crown being configured to receive a first grip and a second grip comprising the staple inserter for placing the surgical staple into a distracted configuration suitable for implantation into a bone. 
     
     
         8 . The system of  claim 1 , wherein the surgical staple comprises a crown coupled with a first transverse portion at a first end and coupled with a second transverse portion at a second end, a first leg and a second leg extending downward and parallelly from opposite ends of the first transverse portion, a third leg and a fourth leg extending downward and parallelly from opposing ends of the second transverse portion. 
     
     
         9 . The system of  claim 8 , wherein a plurality of teeth are disposed on each of the first leg, the second leg, the third leg, and the fourth leg and oriented toward a centerline of the crown. 
     
     
         10 . The system of  claim 8 , wherein the staple inserter includes a first grip and a second grip that share a separation distance comparable with the length of the crown. 
     
     
         11 . The system of  claim 10 , wherein the first grip is configured to engage the crown adjacent to the first transverse portion, and the second grip is configured to engage the crown adjacent to the second transverse portion. 
     
     
         12 . The system of  claim 10 , wherein the first grip and the second grip are configured to engage wing portions disposed at opposite ends of the crown and extending beyond the first transverse portion and the second transverse portion, the wing portions being configured to receive the first grip and the second grip for placing the surgical staple into a distracted configuration suitable for implantation into a bone.